Skin cancer is a serious public health problem, as it is the most often diagnosed cancer. Using technology to its full potential might help doctors improve early detection. Using visible light and the ability to distinguish between benign and malignant cells through light backscatter from subcellular structures, elastic scattering spectroscopy (ESS) technology is used. To help PCPs more effectively refer patients to dermatologists and support their clinical evaluation of skin lesions of concern, a portable ESS device has been created. This two-part study aimed to verify the performance of a portable ESS device in comparison to the gold standard of dermatopathology, and also to determine whether device accessibility improved PCP identification and management of skin cancer.
This blinded, prospective, multicenter clinical validation study was conducted at 22 primary care study sites in the United States (18) and Australia (4). A total of 1005 individuals with 1579 lesions indicative of skin cancer were included. PCP investigators clinically examined lesions before scanning them using the ESS equipment. For suspected skin lesions, clinical treatment was provided in accordance with established standards. Dermatopathology data were utilized as the reference standard for evaluating device performance. An associated utility research comprised 108 PCP readers who evaluated 50 skin lesion cases, a subset chosen at random from the validation study in order to match the lesion breakdown of clinical trial.
The study found the sensitivity of the device for detecting high-risk lesions was 95.5%, with a specificity of 20.7% when compared to 83.0% sensitivity and 54.2% specificity of PCPs for clinically worrisome biopsied lesions. Non-inferiority testing revealed that device performance was comparable to a performance objective of 90%. The device findings dramatically boosted PCP management and diagnostic sensitivity, whereas specificity for diagnosis and referrals decreased. Management performance increased from 0.684 to 0.729. The number of PCPs indicating strong trust in management choices improved in response to device findings. Overall, when compared to gold-standard dermatopathology, the ESS gadget detects skin cancer with great sensitivity.
Source:
Merry SP, Agresta T, Severing EV, et al. Can a Handheld Elastic Scattering Spectroscopy Device Aid Primary Care Physicians in Detection and Management of Skin Cancer? Presented at: Maui Derm NP+PA Fall 2024. Nashville, TN. September 15-18, 2024
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